The effects of tryptophan loading on Attention Deficit Hyperactivity in adults: A remote double blind randomised controlled trial

Background Despite the impact and prevalence of Attention Deficit Hyperactivity Disorder (ADHD), current treatment options remain limited and there is a drive for alternative approaches, including those building on evidence of a role for tryptophan (TRP) and serotonin (5-HT). This study aimed to evaluate the effect of acute TRP loading on attention and impulsivity in adults with ADHD. Trial design and methods We conducted a remote double blind randomised controlled trial (RCT) using TRP loading to examine the effects of a balanced amino acid load in comparison to low and high TRP loading in individuals with ADHD (medicated, N = 48, and unmedicated, N = 46) and controls (N = 50). Participants were randomised into one of three TRP treatment groups using stratified randomisation considering participant group and gender using a 1:1:1 ratio. Baseline testing of attention and impulsivity using the Test of Variables of Attention Task, Delay Discounting Task, and Iowa Gambling Task was followed by consumption of a protein drink (BAL, LOW, or HIGH TRP) before repeated testing. Results and conclusions No effects of TRP were observed for any of the measures. In the present study, TRP loading did not impact on any measure of attention or impulsivity in those with ADHD or Controls. The findings need to be confirmed in another trial with a larger number of patients that also considers additional measures of dietary protein, plasma TRP and aggression. (Registration ID ISRCTN15119603).

4 Risk Checklist: Please indicate if your study involves any of the following risks: a) The research involve participants who are vulnerable or unable to give informed consent or in a dependent position.b) Participants will take part in the study without their consent or knowledge at the time of participation or deception of some kind will be involved.c) There is a risk that the research topic might lead to disclosures from the participant concerning their involvement in illegal activities or other activities that represent a threat to themselves or others.d) The study may induce psychological stress or anxiety, or produce humiliation or cause harm or negative consequences beyond the risks encountered in a participant's usual everyday life.e) There is a foreseeable likelihood that a participant's capacity to give fully informed consent may diminish throughout the course of the project i.e. early stage dementia, brain injury etc. f) The study involves imaging techniques such as MRI scans or ultrasound.g) The study involves sources of non-ionising radiation (e.g.lasers) h) The study involve physically invasive procedures or the collection of bodily materials (including collection of human tissue for purposes such as DNA/RNA analysis) None of the above.
5 Does the study involve the recruitment of participants under the age of 16?

Based on your answers to the above filter questions your research has been categorised as High Risk
You can now access an overview of the available sections of the application by selecting the navigate tile in the action panel on the left.Alternatively you can proceed through each section of the application by selecting the next tile.
Upon submission will be subject to review at the next relevant Research Ethics Subcommittee meeting.Meeting dates and submission deadlines can be found here A Applicant Details

Title
First Name Surname A7 Faculty/Institute/School Please refer to the information icon if you are unsure of your Faculty/Institute/School.
B4 Is this a funded project?
Yes No B5 What are the aims and objectives of the project?
Provide the academic/scientific justification of the project as well as detailing and explaining the principal research question, objectives and hypotheses to be tested.
Please Note: Applications to the BDM and PNM RESC should include a full list of references/citations to back up the academic/scientific justification of the project.
ADHD is a neurodevelopmental disorder characterized by poor attention, heightened impulsivity and hyperactivity (American Psychiatric Association, 2000).Within this, impulsivity can be divided into motor, temporal and cognitive impulsivity (Evenden, 1999; Jentsch et al., 2014; Yang, Vollm, & Khalifa, 2018).Although often considered a childhood disorder, its prevalence in adults is estimated at 2.5-5.2%and, critically, many people who meet the criteria for ADHD in adulthood did not meet the criteria as children (Moffitt et al., 2015).This means that research findings from children with ADHD may not apply to adults with the condition.Irrespective of age, psychostimulants (e.g.amphetamine) are the most common and efficacious treatment.They mainly act on dopamine (DA) and noradrenaline (NA) systems and are effective in over 80% of patients (Dittmann et al., 2014).However, whilst psychostimulants reduce ADHD symptoms, they have side effects ranging from insomnia to tachycardia (Mariani, Mariani, & Levin, 2007) and there are concerns about the drugs being abused (Darredeau, Barrett, Jardin, & Pihl, 2007).It is therefore important that other treatments are explored.
Preclinical studies suggest that other neurotransmitter systems might be involved in ADHD aetiology (e.g.Bolanos et al., 2008) and reduced brain serotonin (5-HT) levels have been reported in a well-validated animal model of ADHD (Sagvolden et al., 2005).Furthermore, altered genes relating to serotonin are implicated in ADHD in human research (Baehne et al., 2009; Grünblatt et al., 2012).Interestingly, dietary precursors can impact the synthesis rate and function of serotonin.Tryptophan (TRP) is such a dietary precursor and an essential amino acid involved in the synthesis of 5-HT which can modulate cognition and behaviour (Silber & Schmitt, 2010).Importantly, for this study, depletion of TRP has been associated with ADHD-like symptoms (Banerjee & Nandagopal, 2015) meaning that increasing tryptophan could offer a novel standalone or adjunct treatment in ADHD.
To date, only a few studies have investigated TRP modulation in adults with ADHD.These studies have largely focused on secondary impairments rather than core symptoms, for example, examining reactive aggression (Kotting et al., 2013; Zimmermann et al., 2012), language processing (Grabemann et al., 2013) and memory processes (Zepf et al., 2013).Only one study to date examine attentional processes (Mette et al., 2013), meaning there is little or no research on the main cognitive symptoms of ADHD.Moreover, in all cases, the studies have used tryptophan depletion to infer a role for tryptophan in treatment, which assumes that those with ADHD have a high enough level of serotonin production for the depletion to offer a significant reduction.This cannot be assumed given that the individuals may have very low levels to begin with.Based on this, the overall aim of the current study is to investigate the effects of moderating tryptophan levels on attention, motor, temporal and cognitive impulsivity in healthy and ADHD participants.To achieve this, we will assess the impact of acute tryptophan loading (low and high TRP supplementation), compared to a balanced (unmoderated tryptophan) control condition on key cognitive ADHD symptoms in: 1. Healthy control participants (HC) and unmedicated adults with a diagnosis of ADHD (ADHD-) to establish the effects of tryptophan on ADHD symptoms.
2. Medicated adults with ADHD (ADHD+) in comparison to unmedicated adults with ADHD (ADHD-) to establish the effectiveness of tryptophan as an adjunct treatment for ADHD.
Specifically, we hypothesise that: 1. Participants with ADHD will perform significantly worse on tasks measuring attention and impulsivity than HC, with ADHD+ performing at an intermediate level between ADHD-and HC.
This hypothesis relates to the fact that ADHD participants will show impaired performance on the tasks used because of their diagnosis and that this will be partially ameliorated by drug treatment.The tasks have been selected because they are known to reveal such impairments and therefore this hypothesis will confirm previous results and allow us to establish baseline performance for the main study hypotheses.
2. There will be a significant effect on attention and impulsivity measures following moderation of TRP levels in HC such that the control condition will produce poorer performance, while the low and high TRP conditions will improve performance in a dose-Project ID: 17983 dependent way.
Given that we cannot assume typical levels of 5HT production in ADHD, we will first examine the effects of different TRP loads in HC participants to be sure that performance can be moderated in a dose-dependent way initially.
3. There will be a significant effect of TRP moderation on attention and impulsivity measures in unmedicated ADHD, with the high TRP condition significantly improving performance.
This hypothesis relates to the fact that TRP may be a suitable standalone treatment but also that there may be differences in the high TRP condition and the low TRP condition to HC due to different basal levels of 5HT.
4. There will be a significant difference in the effects of TRP moderation on attention and impulsivity measures in medicated and unmedicated adults with ADHD.
This hypothesis relates to the fact that TRP may offer an adjunct treatment by further normalising the behaviours in individuals on medication for ADHD.

B6
Where will the research be conducted?i.e in a facility within the college, in a private organisation, in a public place etc The research will be conducted in the testing labs within the Psychology Department at Addison House, Guy's Campus, King's College London.In case of remote data collection, participants will complete all tasks remotely, in their own homes, whilst being assisted by a member of the research team via Skype.
B7 If outside of the UK, please state the country/countries in which data collection is expected to occur.Questionnaire: Participants interested in completing the study will be directed to an online survey which begins with an information sheet and consent form.Participants will have unlimited time to read the study information and, if they choose, give consent to participate.Those giving consent will be then be required to complete a short screening survey consisting of: 1. Confirm inclusion/exclusion criteria (e.g.not gluten or lactose intolerant).
2. Basic demographic questions (age, gender, ethnicity, handedness and years in education) 2. Dietary questions to indicate if the participants is following any special diets at present. 3. A single question asking about ADHD diagnosis (present/absent) followed by the standardised and well-validated Adult ADHD Self-Report Scale (ASRS) (Kessler, Adler, Ames, Demler, Faraone et al, 2005) which provides an indicator of the level of ADHD-like behaviours in those both with and without the condition.
4. Those identifying as having ADHD will be asked to provide details of any medication prescribed for ADHD (dose, duration of use, type used, adherence).
Finally, participants will be asked to provide an email address to be contacted on to arrange the lab visit.
Behavioural/Cognitive Testing: Several computerised cognitive tests will be carried out before and after ingesting a low TRP protein drink or a high TRP protein drink (or control).All tests are established and well-validated and we currently run them in our laboratory.
1. Attention will be measured using a version of the Continuous Performance Task (CPT), which has been found to be highly sensitive to the deficits in ADHD, including in adults (Barkley, Murphy, & Kwasnik, 1996; Epstein, Johnson, Varia, & Conners, 2001; Gansler et al., 1998).The CPT which best differentiates those with ADHD from healthy controls is the Test of Variables of Attention or TOVA task (Grane, Endestad, Pinto, & Solbakk, 2014).Briefly, participants are required to press a letter on a keyboard to respond to a target (or 'Go') stimulus whilst inhibiting responses to nontarget ('No-Go') stimulus.There are two phases of the task, from which different conclusions can be made: i) Phase 1 -Go signals are infrequent, presented in just 22.5% of the trials; ii) Phase 2 -Go signals are frequent, presented in 77.5% of the trials.The first phase provides information about inattention and the second about motor impulsivity.This task takes around 15 mins to complete.
2. Temporal impulsivity can be measured with the Delay-Discounting Task (DDT).This task provides a reliable and valid measure of temporal impulsivity that is elevated in those with ADHD (Hurst, Kepley, McCalla, & Livermore, 2011).The task requires participants to make choices between hypothetical rewards now or at a point in the future for several different delays e.g. 1 week, 2 weeks, 1 month, 3 months, 6 months and 1 year.Responses are used to calculate the 'indifference point' for each delay, that is the point at which the participant switches to receive the delayed reward.The task takes around 10 mins.
3. Cognitive impulsivity will be measured using the Iowa Gambling Task (IGT) in which participants are shown 4 decks of cards (labelled A, B, C, and D) and asked to choose 100 times from the decks (Kovács, Richman, Janka, Maraz, & Andó, 2017), with the test taking around 15 mins.Each time participants choose a card they can win or lose virtual money.Decks A and B give large gains and large losses, whereas decks C and D give small gains and small losses.Decks A and B are riskier cards as in the short term they win more but in the long term they create an overall loss.The task takes around 10 mins.
B9 Provide an explanation in lay language outlining each methodology of the study, as identified in question B8.
This study aims to recruit healthy control participants as well as adults with ADHD.The study will begin with a short online screening questionnaire which will allow us to do two things.Firstly, the survey will allow us to confirm key exclusion criteria e.g.gluten intolerance or following a very restrictive diet (i.e.keto).Secondly, the survey will allow us to match the three groups of participants, for example, for age and handedness and collect information on medication in those reporting to have a diagnosis of ADHD.
Eligible participants will then be contacted to attend a 2-hour lab visit at Addison House, Guy's Campus.On arrival at the lab they will be asked to complete three different cognitive tests on a computer.These tests measure attention and impulsivity and will take the person around 30 mins to complete.After completing the baseline tests, in which we would expect participants with ADHD to perform less well than healthy controls, all participants will be asked to consume a drink which will contain differing amounts of the serotonin precursor tryptophan, an amino acid typically found in our diets.Each participant will have just one drink and this may be high, low, or typical in terms of the amount tryptophan.Once they have consumed the drink, participants will wait 60 mins for the drink to be metabolised before completing the three tests again.In total we expect each participants to be in the lab for around 2 hours.
In case of remote data collection, eligible participants will be required to be available for an online testing session which can be done remotely.Testing should take around 2 hours and will take place via the online testing platform, Gorilla, and will also involve a Skype briefing and debriefing at the beginning and end of the allocated time slot.The researcher will ask the participant to prepare and ingest a drink from a sachet (by adding water), which has been sent to them in advance of their online testing appointment.Full instructions on how the drink should be prepared will be provided.
If the summary of your methodology would be supported by a flowchart please attach this here (an editable flowchart can be found via the link in the guidance icon) Our research uses a 3 x 3 x 2 factorial design.Factor 1, 'ADHD Status', is a between-subjects factor and consists of three distinct participant groups (HC, ADHD+, ADHD-).Factor 2 is also between-subjects with three conditions (low TRP, high TRP and TRP norm'.Factor 3 is a within measures factor and includes the before and after consumption measures.There is no existing data to calculate considering these groups and conditions to sample size.However, similar studies covering components of the current work, indicate small-medium effects sizes, therefore a power analysis assuming this effect size and power of 0.95 was conducted.This suggests that we require a total group size of 144 participants (48 HC, 48 ADHD+, 48 ADHD-).We have planned and costed for this +10% as is typical in human work where some individuals may be excluded (e.g.incomplete data set).This gives a total of 158.

Section C(I): Participants
Project ID: 17983 C2a What are the Inclusion Criteria?Where appropriate explain how you will screen your participants.(the selection criteria should be clearly defined for multiple participant groups) All participants: -Aged between 18-35 years.This age group has been selected to avoid the risk of age-related cognitive decline (Salthouse, 2009).
This will be made clear in the information sheet and we will ask participants to confirm they meet this criteria and provide their age in the screening survey.
Healthy control participants (HC): -In addition to the above, these participants should not have a diagnosis of ADHD.Scores on the Adult ADHD Self-Report Scale, which can also be used in healthy individuals, will provide confirmation a measure of ADHD-like behaviours in this group (Kessler et al., 2005).Note that this scale is not a diagnostic tool and therefore, although high scores on such a scale may indicate a higher likelihood of ADHD they would not provide any diagnostic information not known to the participant.
ADHD Unmedicated (ADHD-) -Existing current diagnosis of the ADHD.The extent of ADHD-like behaviours will be assessed using the Adult ADHD Self-Report Scale as described previously.
-Not receiving ADHD medication and have not received any for a period of at least 3 months.
ADHD Medicated (ADHD+) -Existing current diagnosis of the ADHD.The extent of ADHD-like behaviours will be assessed using the Adult ADHD Self-Report Scale as described previously.
-Currently receiving medication for ADHD (psychostimulant or non-stimulant).Adherence will be confirmed using the approach taken by Safren et al (2007).They adapted a validated scale for medication adherence in HIV to ADHD and used this quick scale to gain a quantitative measure of adherence.This simple scale asks participants the number of pills they should have taken and the number that they have taken in the last two weeks.They noted that almost 80% of individuals reported adherence levels of 80% or more.We will therefore record adherence and consider excluding individuals with less than 80%.By choosing this level, rather than 100% adherence (which is only found in 44% of adults with ADHD) we ensure we have an ecological valid sample.Additionally, participants will be required to take their medication as normal on the day of testing because part of the investigation is to examine the adjunct effects of exercise.They will be asked to confirm this and state the time they last took their medication prior to testing.
Note that the researchers are not allocating to treatment groups.Participants will be allocated based on their existing treatment and those that receive medication will be doing so under the care of their doctor.It is possible to recruit unmedicated individuals with ADHD because many adults choose not to take the psychostimulant treatment.C2b What are the Exclusion Criteria?Where appropriate explain how you will screen your participants.(the selection criteria should be clearly defined for multiple participant groups) The exclusion criteria for enrollment in this study are: -gluten or lactose intolerance, as participants will be asked to ingest a whey protein drink; -current or past diagnosis of nutritional, psychiatric (excluding ADHD) or neurological illnesses; -being pregnant/breastfeeding; -being a smoker (including e-cigarettes); -currently taking medication known to affect the serotonergic system such as antidepressants; -learning disabilities; -following a restrictive diet (e.g.keto), as this might interfere with the experiment.
C3 What are the upper and lower age limits?Provide justification for these where appropriate.
Participants will be aged 18-35.This age group is selected to avoid the risk of age-related cognitive decline (Salthouse, 2009).
Project ID: 17983 C4 How will potential participants be identified and approached?Please note: If different recruitment methods will be used for participant groups, each group should be separately addressed.
Participants will be recruited through institutional volunteer recruitment channels.The institutional recruitment network at King's is highly effective for recruiting healthy participants.Recruitment posters and leaflets will also be advertised on notice boards on campus.We may additionally advertise via websites for support groups e.g.The Adult ADHD Network were we already have research studies advertised and via social media.
C5 Do you have a current or prior relationship with any potential participants?(This includes professional and/or personal relationships) Yes, I do have a current or prior relationships with potential participants.
No, I do not have any current or prior relationships with potential participants.
C6 Gatekeeper Permission: Will you require an individual or organisation to grant you permission to approach/ access your intended participants?This includes gatekeepers contacting participants on your behalf Yes, I will be using a gatekeeper to access potential participants No, I will not be using a gatekeeper to access potential participants C7 Please specify any incentives being offered and a justification for their use.
Participants will be given a £20 Amazon voucher as a 'thank you' for their time.
C8 Will informed consent be sought from all participants?Yes No C8a How will informed consent be obtained for each data collection method/participant group?Who will take consent and how will it be recorded?Note: Justification must be provided if you will not be providing all participants with an information sheet and gaining written consent Consent will first be sought through the screening survey with an online version of the form, after participants have been given the opportunity to read the participant information sheet at their own pace.If eligible and enrolled in the study, consent will be sought again at their arrival at the testing laboratory typically by the Research Assistant on another member of the research team as required.Consent forms will be stored electronically on a restricted-access, password-protected OneDrive or Sharepoint account which will be encrypted using an end-to-end encryption for cloud data.For any data stored on hard drives, this will be encrypted using Bitlocker or similar software.

Informed Consent
Project ID: 17983 example, a participant faints during the procedure.
We do not anticipate any adverse events to occur as a direct result of participation.The screening survey has been set to identify individuals who have lactose or gluten intolerance and these individuals will not be eligible to partake.The only possible adverse event might be mild bloating if participants are not aware of a mild intolerance.Participants are made aware of this risk prior to participation, although all measures will have been taken by the research team to minimise this risk through sourcing high quality protein powders only.
In the event that participants experience these effects, they will do so in the laboratory (because of the timing of consumption) or in their own homes (if we must collect data remotely).In both cases, they will be able to stop testing and be provided with water and a space to rest until they feel better.Given the low risk of a reaction and the likely mild reactions, no urgent care will be necessary, however, participants will be followed up within 48 hrs to check on their well being and provided with NHS guidance (links) on food intolerance.If participants have any adverse reaction that concerns them, they will be advised to contact their GP.
D2 If there are any additional risks or burdens to participants that have not been addressed above, please provide further details and explain how these risks will be mitigated: D3 What are the potential benefits to the participant?
The data collected will provide valuable information about the effects of tryptophan on attention and impulsivity in healthy people and those with ADHD.It is anticipated that the study will provide useful findings about the viability of tryptophan as a standalone or adjunct treatment in ADHD and, therefore, has the potential to be beneficial to individuals diagnosed with the condition in the future.
There are no direct benefits to participants for being part of this study, although those who attend and complete the testing session will receive a £20 Amazon voucher as a 'thank you'.
D4 Will participants be guaranteed complete anonymity in the final report and any further research output/s?

Yes No
D4a Please explain how you will ensure participants remain completely anonymous in the final report or any other research output/s.All participants will be assigned a unique ID in order to enable the research team to invite eligible participants to the testing session.This file will be stored securely on a password-protected and encrypted cloud service to which only the immediate research team has access.All experimental data included in analysis will be free of any identifiable information.All data presented in the final report or any other research outputs will be presented as averages and group comparisons and will not make reference to individual participants.

Section E(I): General Data Protection Regulation Requirements
Project ID: 17983 E1 Does the project involve the collection and/or use of personally identifiable information?Personally identifiable information is data that can be used to identify an individual, either directly or indirectly.This may include names, job titles, photos, video or audio recording, email addresses, usernames, IP addresses, DNA or one or more factors specific to the physical, genetic, mental, economic, cultural, or social identity of that person.See guidance icon for examples of personal data.
Please indicate which of the following applies: a) The project involves the collection and/or use of personally identifiable information b) Personally identifiable information will only be obtained in order to contact potential participants.No further identifying information will be collected as part of the study.
c) No personally identifiable information will be collected and/or used for this project E1b Please indicate which of the following applies: The personal data used for recruitment purposes will not be linked to the anonymous data collected from participants and will not be held for any longer than is necessary for the purposes of recruitment.
The identifiable information used for recruitment purposes will be linked to the data collected from the corresponding participant/s (this includes linking participant details to raw data for withdrawal purposes) E1c Important Notice: General Data Protection Regulation requirement Projects involving the collection and processing of personal data must be registered with the King's Data Protection Register.
Researchers must obtain confirmation of KDPR registration prior to commencing data collection in order to comply with the new General Data Protection Regulation.
I confirm that I will submit a King's Data Protection Registration Form prior to commencing collection Please note: Once you have gained ethical clearance, the important step is that you submit the KDPR form prior to commencing data collection.Providing you have submitted a KDPR for registration, you do not have to await confirmation of registration before commencing data collection.
I confirm that I understand that it is the responsibility of the researcher to ensure that all research data is securely handled and stored during and after the project in compliance with the General Data Protection Regulation (GDPR) and College guidelines: KCL Research Data Management Guidelines KCL guidance on the General Data Protection Regulation E2a Will any data from which participants could be identified be published (this could be direct quotes or biographical data)?
Yes No E3a Will the data be pseudonymised and the identifiable data stored securely and separately from the research data?Yes No

Section E(II) Data Handling, Protection and Storage
Project ID: 17983 E5 Where will research data be stored during and after the study is completed?
All data collected through Qualtrics (the screening survey) and Gorilla (cognitive tests) is automatically encrypted.The downloaded research data will then be stored on a password-protected cloud service, which will be further encrypted using Boxcryptor, an end-toend encryption for cloud data.For any data stored on hard drives, this will be encrypted using Bitlocker or similar software.
The email addresses will be removed from the screening survey data and replaced with a participant ID before storage for the screening data, so that all subsequent data will be associated with only the ID.Email address will be stored separately (with a coding to ID) to allow us to contact the participant.At the end of the study, the file containing email addresses and associated ID will be deleted.
After the study, fully anonymised data sets will be retained for up to 4 years following completion of the study, according to the General Data Protection Regulation (GDPR, 2018).These anonymised data sets will only be accessible to the research team.Should a suitable repository become available for this data, fully anonymised datasets may also be uploaded to a public repository.
E6a Who will have access to participants' personal data during the project?
The researchers will have access to the participants email address and ID to arrange testing which could be linked back to data during the project, although they will be stored separately with research data anonymised.
E7 How long will research data be stored for after the project is completed?Guidance on data retention periods can be found in the King's Data Retention Schedule All data will be securely stored in an anonymised form for four years after study completion, according to the General Data Protection Regulation (GDPR, 2018).Should a suitable online data repository be available, a full set of anonymised data will be placed on the platform to allow future accessibility.Data will be securely stored on a password-protected network computer and on a password-protected OneDrive or Sharepoint account to which only the Principal Investigator and key research team members will have access.
E4 Research Dissemination: How will results be disseminated?If yes detail the following: Name of the substance(s), Amounts to be administered, Number of times substance will be administered, How the product will be obtained and/or stored, prepared (if appropriate) and dispensed/distributed and Route of administration This experiment is a randomised and double-blinded study.The participants will receive one of the following drinks on a single occasion: 1. Control/TRP-norm: protein drink prepared from 40g of unflavoured 100% whey protein isolate mixed with 400ml water.This form of whey protein powder is readily available in supermarkets and health food shops.
2. Low TRP drink: protein drink prepared from 40g of unflavoured 100% whey protein isolate mixed with 1.43g of L-Tryptophan mixed in 400ml water.As with the whey protein powder, tryptophan powder is readily purchased from health food shops as a dietary supplement.
3. High TRP drink: protein drink prepared from 40g of unflavoured 100% whey protein isolate mixed with 5.24g of L-Tryptophan mixed in 400ml water.
The products will be sourced from a health store widely available in the UK and will be stored in a cool and dry cupboard in Addison House, Guy's Campus.If participation occurs face-to-face, the drink will be prepared half an hour in advance of ingestion time in one of the kitchens available in Addison House.If participation occurs remotely, sachets with the already mixed powders will be delivered to the participants' home addresses.Each sachet with come with full instructions on how to store and prepare the drinks ahead of the experimental procedures.
In this case, participants will mix their own drinks following detailed instructions from the research team.The research team will also contact each participant via Skype before the ingestion of the drink to make sure that participants are adequately briefed and have a full understanding of what is expected of them during testing.The members of the research team are experienced in conducting studies involving experimental procedures.All procedures will be piloted before the commencement of recruitment.Furthermore, all experimental procedures will be accompanied by a full set of instructions which will serve as a guide for each testing session.
G8 Provide details of the human tissue licence, where applicable.The study proposal has been peer reviewed within the Department of Psychology, King's College London.

G4
Does the study involve only moderately invasive/intrusive procedures?Yes No G5 Does the study involve other invasive/intrusive procedures?not involve the collection nor the storage of human tissue/bodily materials in any way. of the investigators experience or training which qualifies them to conduct the required procedures.
project involve any of the Risk Assessment criteria outlined in the information icon guidance?Yes No H1a I confirm that I will complete a Risk Assessment Form which will be signed by my Supervisor or Head of Department prior to commencing data collection Yes No Please note: Your department should be able to provide you with a Risk Assessment Form.If they are unable to do so, please contact Health and Safety Services for further advice.H2 I confirm that I have read the exclusion criteria for the College's Clinical Trials and Research Projects Involving Human Subjects Insurance Policy, detailed in the guidance icon, and that: a) This project meets the inclusion criteria of the policy b) This project falls under the exclusion criteria and I have gained approval from the Finance Department, as instructed in the guidance icon c) This project falls under the exclusion criteria but approval has not been granted by the Finance Department Section H: Insurance, Risks and Ethical Issues Project ID: 17983 H3 I confirm that my travel insurance arrangements are as follows: a) I will secure College travel insurance (see guidance icon for further details) b) I will secure personal travel insurance c) I do not require travel insurance as I will conduct the research in my country of legal residence d) I will not secure travel insurance H4 I confirm that if Disclosure & Barring Service clearance is required for my study, this will be obtained prior to the commencement of data collection.details of any other review body approvals or permissions obtained (including gatekeepers, other Ethics Committees, peer review, R&D permission).